Upper limb functional training for stroke survivors

  • Research type

    Research Study

  • Full title

    Feasibility Study of an Upper Limb functional training Programme to support self-management in Stroke Survivors

  • IRAS ID

    254799

  • Contact name

    Khalid Ali

  • Contact email

    khalid.ali@bsuh.nhs.uk

  • Sponsor organisation

    University of Sussex

  • Clinicaltrials.gov Identifier

    NCT05300659

  • Clinicaltrials.gov Identifier

    , 254799

  • Duration of Study in the UK

    1 years, 11 months, 30 days

  • Research summary

    Summary of Research
    This feasibility study will explore the clinical effectiveness of additional upper limb therapy compared to standard care delivered to Stroke Survivors at Sussex Rehabilitation Centre (SRC). Patients will be screened and approached for consent within 2 weeks of admission. Randomisation via Sealed Envelope will allocate treatment group to either routine care or upper limb training for self management plus routine care. If randomised to upper limb training, a patient will undertake 10 therapy sessions with an instructor from the Action for Rehabilitation for Neurological Injury (ARNI) program during their hospital stay. The last two ARNI-led sessions will be filmed by a nurse/carer on either their own tablet/phone or an i-pad. Participants in the ARNI group will be encouraged to continue doing their personalized exercises while in hospital and continued at home. They will also be given a task-training board to take home.
    This randomised controlled trial will measure outcomes of each group over six months. Each patient in the study will have upper limb physical measurements taken by a blinded Research Nurse (RN2) at baseline. Research Nurse (RN1) will gather data in a Clinical Report File from a weekly exercise diary completed by the patient or carer and well-being questionnaires. On discharge, RN2 will conduct upper limb measurements, collect completed hospital diaries and issue new ones to take home. RN1 will give a weekly phone call or text reminders so that patients to complete exercise diaries at home. At 6 months RN2 will do final measurements and complete patient questionnaires in an outpatients Clinic visit.
    We aim to recruit 36 patients and anticipate 30 (83%) will complete the 6 month follow up.
    The study sponsor will be the University of Sussex. However, as the study is run in rehabilitation unit in an NHS hospital, BSUH NHS Trust will host the study.

    Summary of Results
    7 study participants were recruited out of the estimated 36 participants. The study was a randomized controlled trial in which the study participants were to be in two groups (intervention and the control group). Participants in the intervention arm were to receive additional upper limb therapy after stroke in hospital delivered by Action for Rehabilitation from Neurological Injury (ARNI) instructors while the control arm was to receive the usual care. They were to be followed up and reviewed after 6 months.
    However due to research logistic challenges the 7 participants could not be followed up and so no assessments can be made of the ARNI intervention with the baseline data available.

  • REC name

    London - Brighton & Sussex Research Ethics Committee

  • REC reference

    19/LO/1706

  • Date of REC Opinion

    17 Apr 2020

  • REC opinion

    Further Information Favourable Opinion